Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Kafrelsheikh University

Status: Enrolling

Conditions: Simvastatin; Photodynamic Therapy; Periodontal Diseases

Treatments: Procedure: SMV application; Procedure: SMV and antimicrobial photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05031923

waiting..

Details and patient eligibility

About

Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients were all healthy and free from any systemic disease;
• no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
• patients were willing and able to return for multiple follow-up visits;
• good levels of oral hygiene

Exclusion criteria

• Pregnant and lactating female patients,
• smokers,
• alcoholics,
• those receiving any medication that could affect healing of soft or hard tissue

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

SMV and antimicrobial photodynamic therapy

Experimental group

Description:

Application SMV and antimicrobial photodynamic therapy in intrabony defect

Treatment:

Procedure: SMV and antimicrobial photodynamic therapy

SMV application

Active Comparator group

Description:

Application SMV in intrabony defect

Treatment:

Procedure: SMV application